Cleared Traditional

K874056 - OPHTHALMIC DISPOSABLE BLADES
(FDA 510(k) Clearance)

K874056 · Myocure, Inc. · Ophthalmic

Dec 1987

Decision

78d

Days

Class 1

Risk

K874056 is an FDA 510(k) clearance for the OPHTHALMIC DISPOSABLE BLADES. This device is classified as a Knife, Ophthalmic (Class I — General Controls, product code HNN).

Submitted by Myocure, Inc. (Glendale, US). The FDA issued a Cleared decision on December 22, 1987, 78 days after receiving the submission on October 5, 1987.

This device falls under the Ophthalmic FDA review panel. Regulated under 21 CFR 886.4350.

Submission Details

510(k) Number	K874056 FDA.gov
FDA Decision	Cleared SESE
Date Received	October 05, 1987
Decision Date	December 22, 1987
Days to Decision	78 days
Submission Type	Traditional
Review Panel	Ophthalmic (OP)
Summary	—